85/100 · Critical
Manufactured by H2-Pharma, LLC
Quetiapine Adverse Events: High Seriousness and Diverse Reactions
427,224 FDA adverse event reports analyzed
Last updated: 2026-05-12
QUETIAPINE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by H2-Pharma, LLC. Based on analysis of 427,224 FDA adverse event reports, QUETIAPINE has a safety score of 85 out of 100. This score indicates a relatively favorable safety profile, with fewer or less severe adverse events compared to many other tracked medications. The most commonly reported adverse reactions for QUETIAPINE include DRUG INEFFECTIVE, OFF LABEL USE, TOXICITY TO VARIOUS AGENTS, INSOMNIA, FATIGUE. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for QUETIAPINE.
Quetiapine has a safety concern score of 85 out of 100, placing it in the high concern category based on analysis of FDA adverse event data. The FDA has received approximately 427,224 adverse event reports for this medication, which is primarily manufactured by H2-Pharma, Llc.
The most commonly reported adverse events include Drug Ineffective, Off Label Use, Toxicity To Various Agents. Of classified reports, 78.7% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. High percentage of serious adverse events (78.7%) indicates significant safety concerns.
Diverse range of reactions, including psychiatric, metabolic, and cardiovascular issues. Weight increase and diabetes mellitus are among the most common reactions.
Patients taking Quetiapine should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Quetiapine can cause serious drug interactions and should be used with caution, especially with other sedatives or antipsychotics. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Quetiapine received a safety concern score of 85/100 (high concern). This is based on a 78.7% serious event ratio across 185,534 classified reports. The score accounts for 427,224 total adverse event reports and 100 distinct reaction types. This high score reflects a significant proportion of serious adverse events in the reporting data.
Adverse event reports by sex: Female: 102,169, Male: 69,663, Unknown: 516. The most frequently reported age groups are age 43 (3,238 reports), age 54 (3,051 reports), age 44 (2,825 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 185,534 classified reports for QUETIAPINE:
The FDA classifies an adverse event as “serious” if it results in death, hospitalization, disability, congenital anomaly, or requires intervention to prevent permanent damage.
Demographics reflect voluntary FDA adverse event reporting patterns and may not represent the full patient population.
Quetiapine can cause serious drug interactions and should be used with caution, especially with other sedatives or antipsychotics.
If you are taking Quetiapine, here are important things to know. The most commonly reported side effects include drug ineffective, off label use, toxicity to various agents, insomnia, fatigue. While many of these may be mild and temporary, you should contact your healthcare provider if any symptoms are severe or persistent. Monitor patients for signs of weight gain and metabolic changes, especially in those with pre-existing conditions. Closely supervise patients for suicidal ideation and behavior, especially in the first few months of treatment. If you experience a serious adverse reaction, seek emergency medical attention immediately or call 911. You can report side effects to the FDA's MedWatch program at 1-800-FDA-1088.
The FDA continues to monitor Quetiapine's safety, and updates are regularly issued based on new data.
The FDA has received approximately 427,224 adverse event reports associated with Quetiapine. These reports come from healthcare professionals, consumers, and manufacturers through the FDA Adverse Event Reporting System (FAERS). Note that the number of reports does not directly indicate the frequency of side effects, as adverse events are voluntarily reported and may be underrepresented.
The most frequently reported adverse events for Quetiapine include Drug Ineffective, Off Label Use, Toxicity To Various Agents, Insomnia, Fatigue. By volume, the top reported reactions are: Drug Ineffective (12,346 reports), Off Label Use (11,797 reports), Toxicity To Various Agents (9,721 reports). These figures reflect FDA adverse event reports and may not represent the true incidence rate of these side effects in all patients taking Quetiapine.
Out of 185,534 classified reports, 146,090 (78.7%) were classified as serious and 39,444 as non-serious. The FDA classifies an event as "serious" if it results in death, hospitalization, disability, or other medically significant outcomes. A higher serious-event ratio warrants closer attention but does not necessarily mean the drug is unsafe.
Adverse event reports for Quetiapine break down by patient sex as follows: Female: 102,169, Male: 69,663, Unknown: 516. This distribution reflects reporting patterns rather than actual risk differences between groups. Reporting rates can be influenced by prescribing patterns, disease demographics, and reporting behavior.
The most frequently reported age groups for Quetiapine adverse events are: age 43: 3,238 reports, age 54: 3,051 reports, age 44: 2,825 reports, age 50: 2,755 reports, age 52: 2,634 reports. Age-related reporting patterns can reflect both the demographics of the patient population and potential age-related susceptibility to certain side effects.
The primary manufacturer associated with Quetiapine adverse event reports is H2-Pharma, Llc. Multiple manufacturers may produce generic versions of this drug. The manufacturer listed reflects the most frequently reported brand in FDA adverse event data.
Beyond the most common reactions, other reported adverse events for Quetiapine include: Diabetes Mellitus, Weight Increased, Drug Interaction, Somnolence, Nausea. Less common side effects can still be clinically significant. Patients should report any unusual symptoms to their healthcare provider.
You can report adverse events from Quetiapine to the FDA through their MedWatch program at www.fda.gov/medwatch, by calling 1-800-FDA-1088, or by completing Form FDA 3500. Healthcare professionals, consumers, and manufacturers can all submit reports. Reporting helps the FDA monitor drug safety after approval.
Quetiapine has a safety concern score of 85 out of 100 (high concern). This score is calculated from the ratio of serious to non-serious adverse events, the diversity of reported reactions, and the overall volume of reports relative to usage. High percentage of serious adverse events (78.7%) indicates significant safety concerns.
Key safety signals identified in Quetiapine's adverse event data include: High number of serious events, including death and suicide attempts.. Significant increase in diabetes mellitus and weight-related issues.. Multiple reports of drug interactions and overdose.. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Quetiapine can cause serious drug interactions and should be used with caution, especially with other sedatives or antipsychotics. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Quetiapine.
Monitor patients for signs of weight gain and metabolic changes, especially in those with pre-existing conditions. Closely supervise patients for suicidal ideation and behavior, especially in the first few months of treatment.
Quetiapine has 427,224 adverse event reports on file with the FDA. Diverse range of reactions, including psychiatric, metabolic, and cardiovascular issues. The volume of reports for Quetiapine reflects both the drug's usage level and the vigilance of the reporting community.
The FDA continues to monitor Quetiapine's safety, and updates are regularly issued based on new data. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
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